Restriction on Bisphenol A and related bisphenols of similar concern for the environment
Scope of the restriction dossier
On 7 October 2022 the Federal Office for Chemicals (BfC) as the competent German authority for REACH submitted a dossier with a proposal to restrict Bisphenol A and bisphenols of similar concern for the environment (BPS, BPB, BPF and BPAF) to the European Chemicals Agency (ECHA). This dossier was drafted in cooperation with the German Environment Agency (UBA) and aims at reducing the total environmental emissions from the wide dispersive and multifaceted uses of mixtures and articles containing several bisphenols based on their endocrine disrupting properties for the environment. Based on the estimated emission potential, the restriction proposal addresses uses where the bisphenols are present as free monomers separately to those where the bisphenols are chemically bound to a matrix. Additionally, specific restriction conditions for uses with estimated low emission potential were introduced to avoid disproportionality of the proposed restriction. This results in a tiered and complex scope of the restriction proposal.
The conformity of the dossier was confirmed by ECHA’s scientific committees in December 2022, followed by the launch of the public consultation on the proposal on 21 December 2022.
The dossier containing the proposal as well as supporting documents and the comments received during the consultation can be accessed on ECHA’s website on the restriction proposal.
UPDATE: Temporary withdrawal of the restriction proposal
With the end of the six-month public consultation on the dossier, which has been conducted from December 2022 to June 2023, numerous substantial new data were submitted by stakeholders on the emissions and uses of the bisphenols covered in the dossier. Based on the scrutiny of these comments, the German authorities conclude that a significant re-drafting of the underlying logic of the restriction proposal is necessary and benficial to achieve the intended goals of the restriction proposal. This revision is tied to a new scope of the dossier, which would go beyond the actual mandate of assessment of ECHA's scientific committees and will potentially contain elements, which have not yet been commented by stakeholders as part of the submitted restriction proposal.
Therefore, to ensure the necessary care in redrafting and consecutive third-party participation, the German authorities have decided to withdraw the dossier temporarily. It is planned to re-submit the dossier to ECHA once the submitted information has been incorporated and the re-drafting of the scope has been concluded. Upon resubmission, this updated dossier can undergo a new scrutiny of the scientific committees and public consultation. Therefore, BfC has informed ECHA on 21 August about the formal withdrawal of the bisphenols restriction dossier until further notice. A resubmission will be announced via ECHA's Registry of Intentions as soon as the respective schedule has been finalised.
Pre-submission activities for the restriction proposal
Bisphenol A (“BPA”, CAS 80-05-7, EC 201-245-8) has been subjected to substance evaluation by Germany in 2012. Following conclusion of the process, a substance evaluation report for BPA has been published on ECHA’s website.
According to the assessment of the German authorities, Bisphenol A has been found to be an endocrine disruptor for environmental organisms. Consequently, the substance has been identified as a substance of very high concern (SVHC) due to its endocrine disrupting properties for the environment according to REACH article 57f).
Continuous emission into the environmental compartment surface water via sewage treatment plants and a constant pollution of the surface water bodies of BPA have been detected.
The German agencies seek to achieve the reduction of emissions to the environment via a tailored restriction under the REACH framework.
Steady EU-wide emissions into the environment via sewage treatment plant occur. Peak emissions were determined e.g. in the near of paper recycling/production plants and professional laundries. Traffic security systems often contain recycling material and show high residues of BPA leaching directly into the environment. Products containing BPA from indoor and outdoor use may lead to continuous release into the sewage treatment plants. As not only one specific source of steady release can be found but several sources were detected, authorisation would not be sufficient because they exclude imported articles so a wider restriction proposal must be applied.
To avoid regrettable substitution of Bisphenol A especially with regard to drop-in alternatives, it is planned to also address other bisphenols of concern which exhibit similar concern for the environment based on their structural similarity and hazardous properties for the environment.
The German agencies have launched a Call for Evidence via the ECHA website to allow stakeholders to provide additional information before the final dossier will be submitted for formal public consultation in 2021. The Call for Evidence is open to contributions until 15 January 2021 and can be accessed via the link section below.
A virtual information webinar on the planned restriction was held by the involved German agencies on 15 September. Excerpts from this webinar and presented material can be found in the “Downloads” section below.
A second call for evidence was been launched on this national helpdesk website by the German agencies which focussed on potential alternatives and socio-economic impacts of the planned restriction.
The information package accompanying the call for evidence contained further background documents detailing the current information basis on which the proposal is drafted.
The exercise was been launched on 22 October 2021 and was opened until 22 December 2021.